Celltrion’s DiaTrust COVID-19 Ag Home Test Earns EUA

The FDA has issued an Emergency Use Authorization for a COVID-19 test from Celltrion USA, a subsidiary of South Korea-based Healthcare Celltrion.

The over-the-counter DiaTrust COVID-19 Ag Home Test is an immunoassay that detects the spike proteins on the SARS-CoV-2 coronavirus that causes COVID-19 infections.

Samples for the test are either self-collected, or collected by an assisting adult, on a direct nasal swab from people age 14 and up with symptoms of COVID-19 within seven days of the onset of symptoms.